Label: CALM- tribasic calcium phosphate,ferrosoferric phosphate,dibasic potassium phosphate,sodium phosphate, dibasic, heptahydrate and magnesium phosphate, dibasic trihydrate tablet

  • NDC Code(s): 54973-3331-1, 54973-3331-2
  • Packager: Hyland's Inc.
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated November 7, 2022

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  • PURPOSE

    Natural relief of anxiousness, nervousness and irritability

  • Drug Facts

    Active Ingredients

    Purpose

    Calcarea Phosphorica 3X HPUS

    restlessness, anxiousness

    Ferrum Phosphoricum 3X HPUS

    nervousness

    Kali Phosphoricum 3X HPUS

    irritability, anxiousness, nervousness

    Natrum Phosphoricum 3X HPUS

    irritability, anxiousness and apprehensiveness

    Magnesia Phosphorica 3X HPUS

    anxiousness

    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • Warnings

    Stop use and ask a doctor if

    symptoms persist more than 7 days or worsen.

    If pregnant or breastfeeding

    ask a health professional before use.

    Keep out of reach of children

  • Directions

    ■ Use as directed.

    Adults and children 12 years and over: ■ Dissolve 1-2 tablets under tongue 3 times per day. ■ Sudden onset: every 15 minutes until relieved, up to 6 doses.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions?

    www.hylands.com or care@hylands.com

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • Uses

    ■ Helps temporarily relieves symptoms of:

    ■ restlessness ■ anxiousness ■ nervousness

    ■ irritability ■ apprehensiveness

  • Principal Display Panel

    Hyland's

    NATURALS™

    CALM

    STRESS RELIEF*

    • Anxiousness
    • Nervousness
    • Irritability
    • Non-Habit

    Forming

    50

    QUICK-DISSOLVING TABLETS

    carton.

  • INGREDIENTS AND APPEARANCE
    CALM 
    tribasic calcium phosphate,ferrosoferric phosphate,dibasic potassium phosphate,sodium phosphate, dibasic, heptahydrate and magnesium phosphate, dibasic trihydrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE3 [hp_X]
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE3 [hp_X]
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE3 [hp_X]
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE3 [hp_X]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (Off White to Light Grey) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3331-11 in 1 CARTON12/04/2017
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3331-24 in 1 POUCH; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/04/2017
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3331) , pack(54973-3331) , label(54973-3331)
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